BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX SYSTEM MOTOR

    MDR report key: 526738 · Received February 20, 2004

    Report

    Report Number
    1045834-2004-00168
    Event Type
    Malfunction
    Date Received
    February 20, 2004
    Date of Event
    January 16, 2004
    Report Date
    February 16, 2004
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THE HOSE BURST DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLACKMAX SYSTEM MOTOR MOTOR HBB THE ANSPACH EFFORT, INC. BLACKMAX-N 51749C

    Patients

    Seq Age Sex Outcome Treatment
    1 *